Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder

NCT00644969

Last updated date
Study Location
Pfizer Investigational Site
Aurora, Colorado, 80045, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Have a diagnosis (using the SCID-I/P at screening visit) of schizophrenia or schizoaffective disorder and judged to be stable (without hospitalization or acute exacerbation and functioning in society) on psychiatric treatment for at least the past 6 month.

- Current cigarette smokers (at least 15/day during the past year with no period of abstinence greater than 3 months in the past year) male or female, between the ages of 18 and 75 inclusive, who are motivated to stop smoking.

- Score 7 or higher on the Contemplation Ladder at the Screening, Week -1, and Baseline Visits.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- PANSS score >70 at Screen or Baseline Visit.


- Subjects hospitalized within the past six months due to suicidal ideation or suicidal
behavior or subjects considered to have serious suicidal ideation or suicidal behavior
within the past six moth.


- Subjects having active suicidal ideation or behavior identified at Screen, Week -1, or
Baseline Visit.


- Subjects taking Bupropion.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder
Official Title  ICMJE A Phase 3B 12-Week, Double -Blind, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Varenicline Tartrate (CP-526,555) 1 mg BID for Smoking Cessation in Subjects With Schizophrenia and Schizoaffective Disorder.
Brief Summary Study will determine whether patients with schizophrenia or schizoaffective disorder can be helped to quit smoking safely while using varenicline and receiving smoking cessation counseling.
Detailed Description This is a safety study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Drug: placebo
    Randomization 2:1 treatment to placebo
  • Drug: varenicline (CP-526,555)
    One week of titration up to 1mg bid and 11 weeks of dosing at 1mg bid
    Other Name: Chantix, Champix
Study Arms  ICMJE
  • Placebo Comparator: Placebo Arm
    Randomization 2:1 treatment to placebo
    Intervention: Drug: placebo
  • Active Comparator: Treatment Arm
    Intervention: Drug: varenicline (CP-526,555)
Publications * Williams JM, Anthenelli RM, Morris CD, Treadow J, Thompson JR, Yunis C, George TP. A randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of varenicline for smoking cessation in patients with schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2012 May;73(5):654-60. doi: 10.4088/JCP.11m07522. Erratum in: J Clin Psychiatry. 2012 Jul;73(7):1035.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2010)
128
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2008)
120
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a diagnosis (using the SCID-I/P at screening visit) of schizophrenia or schizoaffective disorder and judged to be stable (without hospitalization or acute exacerbation and functioning in society) on psychiatric treatment for at least the past 6 month.
  • Current cigarette smokers (at least 15/day during the past year with no period of abstinence greater than 3 months in the past year) male or female, between the ages of 18 and 75 inclusive, who are motivated to stop smoking.
  • Score 7 or higher on the Contemplation Ladder at the Screening, Week -1, and Baseline Visits.

Exclusion Criteria:

  • PANSS score >70 at Screen or Baseline Visit.
  • Subjects hospitalized within the past six months due to suicidal ideation or suicidal behavior or subjects considered to have serious suicidal ideation or suicidal behavior within the past six moth.
  • Subjects having active suicidal ideation or behavior identified at Screen, Week -1, or Baseline Visit.
  • Subjects taking Bupropion.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00644969
Other Study ID Numbers  ICMJE A3051072
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP